Rheumatoid Arthritis Clinical Trial
This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to local label for 6 months from start of treatment.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients, >/= 18 years of age - Moderate to severe rheumatoid arthritis - Patients initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including patients who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit Exclusion Criteria: - RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit - Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use - Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra - History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients on RoActemra/Actemra treatment 6 months after initiation of treatment | approximately 3 years | No | |
Primary | Rates of dose modifications/interruptions | approximately 3 years | No | |
Primary | Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment | approximately 3 years | No | |
Primary | Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR | approximately 3 years | No | |
Primary | Efficacy: Monotherapy versus combination therapy | approximately 3 years | No | |
Primary | Laboratory parameters prior to and during infective adverse events and serious adverse events | approximately 3 years | No | |
Primary | Safety: Incidence of adverse events | approximately 3 years | No | |
Primary | Quality of life: HAQ-DI/VAS-Fatigue/FACIT-Fatigue/Patient Global Assessment of disease activity | approximately 3 years | No |
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